Paclitaxel in Treating Women With Recurrent Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Registration Number
- NCT00003130
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of paclitaxel in treating women who have recurrent solid tumors.
- Detailed Description
OBJECTIVES: I. Evaluate the relationships between body surface area (BSA) and toxic effects, BSA and pharmacokinetics, and pharmacokinetics and toxic effects in women with recurrent solid tumors who receive a fixed total dose of paclitaxel. II. Determine the toxic effects of paclitaxel in these patients. III. Assess the pharmacokinetics of paclitaxel in these patients.
OUTLINE: Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1. Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24 hours after the start of the infusion during course 1 only. Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients are evaluated for response after the second course. Patients are followed at the discretion of the physician.
PROJECTED ACCRUAL: A total of 50 patients will be accrued over 13 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description paclitaxel paclitaxel Patients receive single fixed dose intravenous paclitaxel over 3 hours on day 1. Blood samples must be drawn prior to the first paclitaxel infusion and then at 1, 6, and 24 hours after the start of the infusion during course 1 only. Treatment courses of intravenous paclitaxel are repeated every 3 weeks at the discretion of the treating physician. Patients are evaluated for response after the second course. Patients are followed at the discretion of the physician.
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (34)
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Ellis Fischel Cancer Center - Columbia
🇺🇸Columbia, Missouri, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
CCOP - Southern Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
University of California San Diego Cancer Center
🇺🇸La Jolla, California, United States
CCOP - Mount Sinai Medical Center
🇺🇸Miami Beach, Florida, United States
University of Illinois at Chicago Health Sciences Center
🇺🇸Chicago, Illinois, United States
Holden Comprehensive Cancer Center at The University of Iowa
🇺🇸Iowa City, Iowa, United States
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
🇺🇸Baltimore, Maryland, United States
Barnes-Jewish Hospital
🇺🇸Saint Louis, Missouri, United States
University of Massachusetts Memorial Medical Center
🇺🇸Worcester, Massachusetts, United States
Roswell Park Cancer Institute
🇺🇸Buffalo, New York, United States
St. Joseph's Hospital and Medical Center
🇺🇸Paterson, New Jersey, United States
CCOP - North Shore University Hospital
🇺🇸Manhasset, New York, United States
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
🇺🇸Syracuse, New York, United States
New York Presbyterian Hospital - Cornell Campus
🇺🇸New York, New York, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸New York, New York, United States
Mount Sinai Medical Center, NY
🇺🇸New York, New York, United States
State University of New York - Upstate Medical University
🇺🇸Syracuse, New York, United States
Lineberger Comprehensive Cancer Center, UNC
🇺🇸Chapel Hill, North Carolina, United States
CCOP - Southeast Cancer Control Consortium
🇺🇸Winston-Salem, North Carolina, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Tennessee, Memphis Cancer Center
🇺🇸Memphis, Tennessee, United States
Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
MBCCOP - Massey Cancer Center
🇺🇸Richmond, Virginia, United States
Duke Comprehensive Cancer Center
🇺🇸Durham, North Carolina, United States
UCSF Cancer Center and Cancer Research Institute
🇺🇸San Francisco, California, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
CCOP - Christiana Care Health Services
🇺🇸Wilmington, Delaware, United States
Norris Cotton Cancer Center
🇺🇸Lebanon, New Hampshire, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States